Just the facts: Dr. Rick Bright, the FDA and COVID-19 drugs
By Stephanie M. Sellers
Dr. Rick Bright was fired in April from his position as director of the HHS Biomedical Advanced Research and Development Authority. It is alleged that he resisted the widespread use of hydroxychloroquine to treat COVID-19.
This article will cover studies in the U.S. and abroad, their findings and recommendations and is written for critical thinkers.
HOSPITALIZED PATIENTS: A study conducted in the U.S. in April 2020 on the use of a combination of hydroxychloroquine and azithromycin (HY/AZ) to treat COVID-19 recommends that patients be continually studied for heart irregularities. The study suggests that patients with chronic diseases be monitored more closely for heart irregularities and that patients with severe cases of COVID-19 be more closely monitored.
Of the 84 COVID-19 patients in the clinical study, nine (11%) developed prolonged heart irregularities, arrhythmia, specifically, a form of polymorphic ventricular tachycardia. These nine were considered a high risk group and none of them experienced a sudden cardiac event. Out of these nine, five had a normal heart function at baseline.
Of the 84, four died from multi-organ failure, without evidence of arrhythmia and without life-threatening arrhythmia.
Of the 84, 64 patients remained admitted to the hospital and 16 patients were discharged.
The clinical study states that young healthy volunteers treated with the same combination of drugs developed mild arrhythmia. The U.S. study does not recommend this combination.
Support for this combination of drugs comes from sources outside of the U.S.
In a clinical study by the French government in March 2020, which speculated on the potential risk of severe heart irregularities induced by the association of the two drugs, international recommendation for the combination was made:
“We therefore recommend that COVID-19 patients be treated with hydroxychloroquine and azithromycin to cure their infection and to limit the transmission of the virus to other people in order to curb the spread of COVID-19 in the world.”
Another, more recent, U.S. study conducted at New York-Presbyterian Hospital (NYP) revealed no significant association between treatment with this combination and recovery or not.
An investigation on the metropolitan New York influx of COVID-19 patients was released on May 11, 2020 from JAMA. “Among patients hospitalized in metropolitan New York with COVID-19, treatment with hydroxychloroquine, azithromycin, or both, compared with neither treatment, was not significantly associated with differences in in-hospital mortality. However, the interpretation of these findings may be limited by the observational design.” Read about the limitations.
All the above studies included severely ill patients admitted into hospitals.
In April 2020, the Association of American Physicians and Surgeons (AAPS) presented a recommendation for hydroxychloroquine and presented evidence. The evidence states, “The HCQ-AZ combination, when started immediately after diagnosis, appears to be a safe and efficient treatment for COVID-19, with a mortality rate of 0.5%, in elderly patients. It avoids worsening and clears virus persistence and contagious infectivity in most cases.”
“Most states are making it difficult for physicians to prescribe or pharmacists to dispense these medications,” AAPS said.
Recent, Peer-reviewed studies recommend hydroxychloroquine. But the FDA has restricted its use to only those in hospitals in the setting of a clinical study.
The restrictive use of this drug facilitates the less-than favorable recommendations and pushes the agenda of creating new drugs and approving new drugs.
AAPS said that hydroxychloroquine has a 90% chance of helping COVID-19 patients.
During a U.S. government study of the experimental intravenous drug, remdesivir, in April 2020, the stock market fluctuated over the limited data made available from the therapy from Gilead Sciences.
As early as Feb. 2020, the Gates Foundation had pledged $100 million into research and development for drugs and vaccines for the new coronavirus.
Bright’s Linkedin About description lists his many attributes, including his “proven ability to establish and expand partnerships that have tangible results, most importantly, new FDA-approved and marketed medicines and tools to detect, protect, mitigate and treat people from multiple infectious disease and chemical, biological, nuclear and radiological threats.”
The U.S. government study did not reveal a lot about how well remdesivir works because there was not a group of patients who were untreated. No one wants to be injected with a placebo when sick with a life-threatening disease, except maybe in China, where they did have a control group. Their study revealed that there was no difference in those treated with remdesivir and not.
However, the U.S. government’s FDA has released Gilead’s remdesivir for emergency use.
According to researchers, the estimated cost to manufacture remdesivir is 93 cents for a day’s supply, but Gilead disagrees with that estimate.
The cost for hydroxychloroquine, the decades-old malaria drug that was repeatedly touted by President Trump, is only 8 cents.
In 2017, during a forum on pandemic preparedness, Dr. Anthony Fauci said, “the Trump administration will not only be challenged by ongoing global health threats such as influenza and HIV, but also a surprise disease outbreak.”
Fauci has served as the U.S. Director of the National Institute of Allergy and Infectious Diseases since 1984.
Cheers!
References
Rubin Eric J., Harrington David P., Hogan Joseph W., Gatsonis Constantine, Baden Lindsey R., Hamel Mary Beth. (2020) The Urgency of Care during the Covid-19 Pandemic — Learning as We Go. N Engl J Med DOI: 10.1056/NEJMe2015903.
AAPS 90% chance https://aapsonline.org/hcq-90-percent-chance/
Sequential CQ / HCQ Research Papers and Reports
January to April 20, 2020
https://docs.google.com/document/d/1545C_dJWMIAgqeLEsfo2U8Kq5WprDuARXrJl6N1aDjY/edit
From Linkedin Rick Bright aka Rick B.
About
Impactful, practical, and innovative leader. Hyper-focused on improving healthcare (medicines, tools, quality, and access), reaching the unreachable, ensuring that everyone, everywhere has access to lifesaving medicines when and where they need them. Experienced leader in pharmaceutical, biotech, government administration and global NGOs with a demonstrated history of bridging each culture through strong, flexible, and forward-leaning public-private-partnerships. Proven ability to establish and expand partnerships that have tangible results, most importantly, new FDA-approved and marketed medicines and tools to detect, protect, mitigate, and treat people from multiple infectious disease and chemical, biological, nuclear, and radiological threats.
Bill and Melinda Gates and Mike Bloomberg are listed as his interests in Linkedin. These individuals are known Trump opponents. https://www.usatoday.com/story/news/politics/2020/05/05/rick-bright-files-whistleblower-complaint-against-trump-administration/3023905001/
· U.S. April 2020, Clinical study w/ 84 https://www.nature.com/articles/s41591-020-0888-2 Chorin, E., Dai, M., Shulman, E. et al. The QT interval in patients with COVID-19 treated with hydroxychloroquine and azithromycin. Nat Med (2020). https://doi.org/10.1038/s41591-020-0888-2
· FRENCH Study on meds International Journal of Antimicrobial Agents
Available online 20 March 2020, 105949
In Press, Journal Pre-proof What are Journal Pre-proof articles?
Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial
Show more
https://doi.org/10.1016/j.ijantimicag.2020.105949
https://www.sciencedirect.com/science/article/pii/S0924857920300996?via%3Dihub
Remdesivir drug https://www.statnews.com/2020/04/27/the-world-wants-answers-on-gileads-covid-19-drug-experts-worry-next-studies-may-increase-uncertainty/
a Gilead spokesman wrote to say “we disagree with the findings of this study, which do not accurately reflect the true cost to manufacture remdesivir at scale.
